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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Stellarex - 00813132023133

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm
Spectranetics Corporation
AB35SX050120080
In Commercial Distribution

  • 00813132023133 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050120080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023126

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm
Spectranetics Corporation
AB35SX050080080
In Commercial Distribution

  • 00813132023126 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050080080

  • Peripheral angioplasty balloon catheter, drug-coated

Stellarex - 00813132023119

Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm
Spectranetics Corporation
AB35SX050040080
In Commercial Distribution

  • 00813132023119 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter
AB35SX050040080

  • Peripheral angioplasty balloon catheter, drug-coated

EverFlex - 00821684051405

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-06200120
In Commercial Distribution

  • 00821684051405 ()

  • Working Length,120,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 4.5-5.5; MM;
  • Length: 200 Millimeter
  • Catheter Gauge: 5 French
  • Outer Diameter: 6 Millimeter
EVD35-06200120

  • Peripheral artery stent, bare-metal

EverFlex - 00821684051726

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-07200150
In Commercial Distribution

  • 00821684051726 ()

  • Catheter Gauge: 5 French
  • Working Length,150,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 5.5-6.5; MM;
  • Length: 200 Millimeter
  • Outer Diameter: 7 Millimeter
EVD35-07200150

  • Peripheral artery stent, bare-metal

EverFlex - 00821684051641

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-06200150
In Commercial Distribution

  • 00821684051641 ()

  • Length: 200 Millimeter
  • Catheter Gauge: 5 French
  • Working Length,150,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 4.5-5.5; MM;
  • Outer Diameter: 6 Millimeter
EVD35-06200150

  • Peripheral artery stent, bare-metal

EverFlex - 00821684051481

Self-expanding Peripheral Stent with Entrust Delivery System
Covidien LP
EVD35-07200120
In Commercial Distribution

  • 00821684051481 ()

  • Length: 200 Millimeter
  • Working Length,120,Centimeter;Compatible Guidewire,.035,Inch; lumen diameter 5.5-6.5; MM;
  • Outer Diameter: 7 Millimeter
  • Catheter Gauge: 5 French
EVD35-07200120

  • Peripheral artery stent, bare-metal

SurVeil DCB - 00812339030432

SurVeil DCB 5.0mm x 120mm x 135cm
Surmodics, Inc.
SRV03513505012
In Commercial Distribution

  • 00812339030432 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

SurVeil DCB - 00812339030425

SurVeil DCB 5.0mm x 100mm x 135cm
Surmodics, Inc.
SRV03513505010
In Commercial Distribution

  • 00812339030425 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 100 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

SurVeil DCB - 00812339030418

SurVeil DCB 5.0mm x 80mm x 135cm
Surmodics, Inc.
SRV03513505080
In Commercial Distribution

  • 00812339030418 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Length: 80 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
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